ESTRADIOL; NORETHINDRONE ACETATE - Generic Drug Details
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What are the generic sources for estradiol; norethindrone acetate and what is the scope of freedom to operate?
Estradiol; norethindrone acetate
is the generic ingredient in six branded drugs marketed by Noven Pharms Inc, Amneal, Lupin Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Teva Pharms Usa, Xiromed, Aurobindo Pharma Ltd, and Sumitomo Pharma, and is included in eleven NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Nine suppliers are listed for this compound.
Summary for ESTRADIOL; NORETHINDRONE ACETATE
| US Patents: | 7 |
| Tradenames: | 6 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 9 |
| Clinical Trials: | 36 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ESTRADIOL; NORETHINDRONE ACETATE |
| DailyMed Link: | ESTRADIOL; NORETHINDRONE ACETATE at DailyMed |
Recent Clinical Trials for ESTRADIOL; NORETHINDRONE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bio Genuine (Shanghai) Biotech Co., Ltd. | Phase 3 |
| University of Chicago | Phase 4 |
| Myovant Sciences GmbH | Phase 4 |
Pharmacology for ESTRADIOL; NORETHINDRONE ACETATE
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ESTRADIOL; NORETHINDRONE ACETATE
US Patents and Regulatory Information for ESTRADIOL; NORETHINDRONE ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sumitomo Pharma | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Teva Pharms Usa | ESTRADIOL AND NORETHINDRONE ACETATE | estradiol; norethindrone acetate | TABLET;ORAL | 200747-001 | Mar 8, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Xiromed | ESTRADIOL AND NORETHINDRONE ACETATE | estradiol; norethindrone acetate | TABLET;ORAL | 207261-001 | Feb 10, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Barr | ESTRADIOL AND NORETHINDRONE ACETATE | estradiol; norethindrone acetate | TABLET;ORAL | 079193-001 | May 11, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Ltd | ETYQA | estradiol; norethindrone acetate | TABLET;ORAL | 214729-002 | Jun 30, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ESTRADIOL; NORETHINDRONE ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-001 | Aug 7, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-002 | Aug 7, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-001 | Aug 7, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-002 | Aug 7, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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